Disparities in Results of Immune Checkpoint Inhibitor Treatment (DiRECT): A Prospective Cohort Study of Cancer Survivors Treated With Anti-PD-1/Anti-PD-L1 Immunotherapy in a Community Oncology Setting
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,100
- 试验地点
- 259
- 主要终点
- Racial differences in the incidence of Common Terminology Criteria for Adverse Events (CTCAE) grade 2-5 immune-related adverse reactions (irAEs)
研究概览
简要总结
This study compares treatment outcomes between patients of African American/Black (AA) ancestry and European American/White (EA) ancestry currently receiving immune checkpoint inhibitor treatment. Collecting samples of blood and saliva and health and treatment information from racially diverse patients receiving immune checkpoint inhibitor treatment over time may help doctors better understand health care disparities among all cancer patients.
详细描述
PRIMARY OBJECTIVE:
I. To compare incidence of Common Terminology Criteria for Adverse Events (CTCAE) grade 2-5 immune-related adverse reactions (irAEs) between African American (AA) and European American (EA) patients within the first year of starting immune checkpoint inhibitor (ICI) treatment.
SECONDARY OBJECTIVES:
I. To compare objective response rate (ORR) to ICI treatment between AA and EA patients within the first year of starting ICI treatment.
II. To compare health-related quality of life (HRQOL) measured using the Patient Reported Outcomes Measurement Information System (PROMIS) Preference (Patient Reported Outcomes [PRO] Pr) summary score and Functional Assessment of Cancer Therapy-Immune Checkpoint Modulator (FACT-ICM) between AA and EA patients within 1 year of starting ICI treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be 18 years of age or older
- •Self-identify as African/African American/black (AA), or European American/ Caucasian/white (EA)
- •Patients may identify a Hispanic/Latino ethnicity in combination with an AA or EA racial identity
- •Have a current diagnosis of invasive cancer at stage I-IV
- •Patients may have a history of previous cancer diagnosis and cancer treatment not involving immunotherapy
- •Be scheduled to receive anti-PD-1/-L1 ICI-containing therapy alone or in combination with co-treatments (including alternative ICIs)
- •Be able to speak and read English or Spanish
- •Be able to provide informed consent
排除标准
- •Identify as Asian, Pacific Islander, or American Indian/Alaskan Native
- •Be diagnosed with melanoma (because melanoma is very rare in AAs)
- •Currently participate in any trials of a cancer therapeutic nature; participation in noninterventional trial, or trials of symptom control or supportive nature is allowed; participation in future cancer therapeutic trials after completing the A2 assessment (e.g., after the second infusion of ICIs) is also allowed
- •Have received prior immunotherapy for cancer, including checkpoint inhibitors, chimeric antigen receptor (CAR)-T therapy, cytokine therapy, and/or Bacillus Calmette-Guerin (BCG) for bladder cancer
研究组 & 干预措施
Observational (questionnaire, biospecimen, medical records))
Patients complete questionnaires and undergo collection of blood, saliva and optional stool samples before 1st and 2nd infusion of immunotherapy. Patients also complete additional questionnaires undergo additional collection of blood samples 6 months after 1st infusion of immunotherapy and then every year after 1st infusion of immunotherapy. A tumor sample will also be collected at the beginning of the study and patients medical records will be reviewed. Patients may also optionally complete an interview following their 2nd infusion of immunotherapy.
干预措施: Biospecimen Collection (Procedure)
Observational (questionnaire, biospecimen, medical records))
Patients complete questionnaires and undergo collection of blood, saliva and optional stool samples before 1st and 2nd infusion of immunotherapy. Patients also complete additional questionnaires undergo additional collection of blood samples 6 months after 1st infusion of immunotherapy and then every year after 1st infusion of immunotherapy. A tumor sample will also be collected at the beginning of the study and patients medical records will be reviewed. Patients may also optionally complete an interview following their 2nd infusion of immunotherapy.
干预措施: Electronic Health Record Review (Other)
Observational (questionnaire, biospecimen, medical records))
Patients complete questionnaires and undergo collection of blood, saliva and optional stool samples before 1st and 2nd infusion of immunotherapy. Patients also complete additional questionnaires undergo additional collection of blood samples 6 months after 1st infusion of immunotherapy and then every year after 1st infusion of immunotherapy. A tumor sample will also be collected at the beginning of the study and patients medical records will be reviewed. Patients may also optionally complete an interview following their 2nd infusion of immunotherapy.
干预措施: Interview (Other)
Observational (questionnaire, biospecimen, medical records))
Patients complete questionnaires and undergo collection of blood, saliva and optional stool samples before 1st and 2nd infusion of immunotherapy. Patients also complete additional questionnaires undergo additional collection of blood samples 6 months after 1st infusion of immunotherapy and then every year after 1st infusion of immunotherapy. A tumor sample will also be collected at the beginning of the study and patients medical records will be reviewed. Patients may also optionally complete an interview following their 2nd infusion of immunotherapy.
干预措施: Quality-of-Life Assessment (Other)
Observational (questionnaire, biospecimen, medical records))
Patients complete questionnaires and undergo collection of blood, saliva and optional stool samples before 1st and 2nd infusion of immunotherapy. Patients also complete additional questionnaires undergo additional collection of blood samples 6 months after 1st infusion of immunotherapy and then every year after 1st infusion of immunotherapy. A tumor sample will also be collected at the beginning of the study and patients medical records will be reviewed. Patients may also optionally complete an interview following their 2nd infusion of immunotherapy.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Racial differences in the incidence of Common Terminology Criteria for Adverse Events (CTCAE) grade 2-5 immune-related adverse reactions (irAEs)
时间窗: Within 1 year after starting immune checkpoint inhibitor (ICI) treatment
Will be evaluated in bivariate analysis by Chi-square, Wilcoxon rank-sum test, or two sample t-tests.
次要结局
- Racial differences in overall response rate (ORR) between African American (AA) and European American (EA) patients(Within 1 year after starting ICI treatment)
- Health-related quality of life (HRQOL) - PROPr(Within 1 year after starting ICI treatment)
- Health-related quality of life (HRQOL) - FACT-ICM(Within 1 year after starting ICI treatment)
研究者
Charles Kamen
URCC Study Chair
University of Rochester NCORP Research Base